Post-operative iron defieciency MedDRA version: 19.0 Level: LLT Classification code 10002062 Term: Anaemia iron deficiency System Organ Class: 100000004851
Conditions
Interventions
Product Name: Feramyl
Product Code: B03AC
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Iron (III) hydroxide hydroxyethyl starch glucoheptonic acid complex
CAS Number: CAS 15
Current
Sponsors
Serumwerk Bernburg AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent given prior to any trial procedures performed 2. Male or female aged = 18years at the time of signing the informed consent 3. Cardiac surgery performed and the subject has a low mortality risk according to Euro SCORE II =65 years) yes F.1.3.1 Number of subjects for this age range 7
Exclusion criteria
Exclusion criteria: 1. Body weight less than 50 kg 2.Currently experiencing an ongoing bleeding >50 ml/h for the last 3 hours before start of infusion 3.Unexplained anaemia or anaemia due to other aetiology; untreated Vitamin B12 or folate deficiency or hemoglobinopathy 4.Anticipated medical need for erythropoetin during the trial period 5.Known hypersensitivity to iron, hydroxyethylstarch or any excipients of the investigational products 6.Known drug allergy, immunological or inflammatory diseases, severe asthma, eczema or atopy 7.Preoperative anaemia treatment within 3 months prior to screening 8.Ferritin > 800 ng/ml 9.Imminent dialysis 10.Infection (T > 38.5°C or subject on non-prophylactic antibiotics) 11.Chronic liver disease or screening ALAT or ASAT above three times the upper limit of the normal range 12.Renal disease defined as proteinuria and s-creatinine > 150 µmol/l 13.Primary hematologic disease 14.Known malignant disease/cancer within the last 5 years 15.Insulin treated diabetes 16.Rheumatoid arthritis with active joint inflammation 17.History (current or past) of drug or alcohol abuse 18.Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods as required by local regulations and practice 19.Known or suspected of not being able to comply with the trial protocol (e.g. due to psychological disorders or other conditions). 20.Receipt of any investigational medicinal products within the last 90 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate dose proportionality of single dose Feramyl® given as 200 mg, 500 mg and 1500 mg i.v. infusion in terms of total iron in plasma ;Secondary Objective: To evaluate general safety and tolerability of Feramyl® given as 200 mg, 500 mg and 1500 mg i.v. infusion to that of 500 mg Ferinject® i.v. infusion To evaluate the early phase iron parameters of Feramyl® given as 200 mg, 500 mg and 1500 mg i.v. infusion and compare Feramyl® 500 mg i.v. infusion to that of 500 mg Ferinject® i.v. infusion To evaluate urine iron parameters of Feramyl® given as 200 mg, 500 mg and 1500 mg i.v. infusion and compare Feramyl® 500 mg i.v. infusion to that of 500 mg Ferinject® i.v. infusion To characterize the pharmacokinetic parameters of Feramyl® given as 200 mg, 500 mg and 1500 mg i.v. infusion and compare Feramyl® 500 mg i.v. infusion to that of 500 mg Ferinject® i.v. infusion in terms of total iron in plasma ;Primary end point(s): Total iron in plasma: AUC(0-8) and Cmax following infusion;Timepoint(s) of evaluation of this end point: t= 0-8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): General safety and tolerability measures following infusion: - Biochemistry and haematology at t= 0 (start of infusion), 8, 24, 48 and 72 hours following infusion - Blood pressure (BP) and heart rate (HR) at t= 0 (start of infusion), 15 min (end of infusion), 30 min, 60 min, 2, 3, 4, 5, 6, 7, 8, 24, 48 and 72 hours following infusion - CAEs: Infusion site reactions, hypersensitivity reactions, all-cause mortalities -Hypersensitivity reactions: To evaluate this the BP/HR at t= 15 min (end of infusion), 30 min, and 1 hour following infusion will be used - Adverse Events - TSAT, haemoglobin and ferritin at t= 0 (start of infusion), 8, 24, 48 and 72 hours following infusion - Urine iron during the four periods: 0-8 hours, 8-24 hours, 24-48 hours and 48-72 hours following infusion - Total iron in plasma: AUC(0-72), Tmax, ?z, t1/2, Vz, Cl. Where t= sampling time points (0 (start of infusion), 15 min (end of infusion), 30 min, 60 min, 2, 3, 4, 5, 6, 7, 8, 24, 48 and 72 hours) following infusion. ;Timepoint(s) of evaluation of this end point: Added to endpoints; see E.5.2 | — |
Countries
Denmark
Contacts
Public ContactAnnette Stender
KLIFO A/S
Outcome results
None listed